Monitoring for early signs of lymphedema in breast cancer patients
Prospective Surveillance for Breast Cancer-Related Lymphedema: A Randomized Trial
This study is testing if early monitoring for swelling in the arms can help women who have had breast cancer surgery and lymph nodes removed avoid long-term lymphedema.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Copenhagen and 2 other locations) |
| Trial ID | NCT04522648 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a prospective surveillance program aimed at the early detection and management of breast cancer-related lymphedema. It involves women scheduled for breast cancer surgery at five hospitals in Denmark, who will undergo BIS measurements and self-measurements of arm circumference. Participants will be randomized into intervention or control groups after surgery, specifically those who have had more than six lymph nodes removed and are set to receive radiation therapy. The study aims to determine if early monitoring can reduce the prevalence of chronic lymphedema.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older undergoing surgery for breast cancer with more than six lymph nodes removed.
Not a fit: Patients with pre-existing lymphedema or those who have had fewer than six lymph nodes removed will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of chronic lymphedema in breast cancer survivors.
How similar studies have performed: Previous studies have shown promise in early detection and management of lymphedema, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * female; * ≥18 years; * surgery for breast cancer (unilateral and bilateral) including ALDN with \>6 lymph nodes removed; * can effectively communicate verbally in Danish; Exclusion Criteria: * surgery for breast cancer with SLNB or \< 6 nodes removed; * pre-existing lymphedema (primary or secondary); * previous treatment for breast cancer; * pace maker; * conditions known to cause swelling (pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis or deep vein thrombosis in the arms).
Where this trial is running
Copenhagen and 2 other locations
- Copenhagen University Hospital Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Herlev Hospital — Herlev, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Study coordinator: Bolette S Rafn, PhD
- Email: bolette.skjoedt.rafn@regionh.dk
- Phone: +45 22913873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.